Supraciliary microstent implantation for open-angle glaucoma: multicentre 3-year outcomes

OBJECTIVE: To describe the safety and effectiveness of CyPass supraciliary microstent implantation alone in eyes with open-angle glaucoma (OAG) followed up for up to 3 years. METHODS AND ANALYSIS: This registry study included subjects with primary or secondary OAG who underwent CyPass Micro-Stent implantation alone at 12 sites in four European countries to reduce intraocular pressure (IOP) and/or use of IOP-lowering medications. The primary safety outcome was the incidence of adverse events. Secondary efficacy outcomes included mean changes from baseline in IOP and IOP-lowering medications. Eyes were subgrouped into those with low (< 21 mm Hg) and high (> 21 mm Hg) baseline IOP. RESULTS: This study included 225 eyes of 178 patients, with mean baseline IOP of 22.6 ± 6.7 mm Hg and a mean 2.2 ± 1.2 medications per eye. Common ocular adverse events included device obstruction (10.2%), IOP elevation > 10 mm Hg during follow-up (8.9%), retinal complications (4.4%) and loss of > 2 lines of best-corrected visual acuity (2.7%). Seventy-one eyes (31.6%) required secondary glaucoma surgery, with trabeculectomy (33 eyes) and second microstent implantation (13 eyes) being most common. At months 6–36, mean IOP reductions ranged from 4.4 to 5.1 mm Hg (15.8%–19.5%) and mean medication reductions from 0.2 to 1.2 (9.1%–54.5%). Mean IOP reduction was greater in eyes with higher than lower baseline IOP. Both subgroups showed reductions of 0.5–1.0 medication at 12–18 months. CONCLUSION: CyPass microstent implantation demonstrated a safety profile consistent with other minimally invasive glaucoma surgeries and effectively lowered IOP for up to 3 years in eyes with OAG.